Method for endoluminally or laparoscopically excising a tissue sample from areas in a patient&#39;s body, traction means and kit

ABSTRACT

Traction means ( 14 ) for excising a tissue sample comprising a distal portion ( 14   a ), comprising at least one clip ( 20 ) suitable for being fixed to at least one portion ( 12 ) of tissue to be excised and a proximal portion ( 14   b ) suitable for being subjected to traction. Said at least one clip ( 20 ) is suitable for being connected to a distal end ( 22   a ) of a suture ( 22 ) to pull the tissue to be excised, said suture ( 22 ) extending between said distal end ( 22   a ) and a proximal end corresponding to the proximal portion of said traction means ( 14 ). Moreover, said at least one clip ( 20 ) is connected to a ring ( 24 ) formed at a distal end ( 24   a ) of said suture ( 22 ) to pull the tissue to be excised.

The present invention concerns a method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient'sbody.

In accordance with a further aspect, the present invention also concernstraction means for excising a tissue sample and a kit for endoluminallyor laparoscopically excising a tissue sample from areas in a patient'sbody.

In particular, the present invention concerns a method suitable forcovering low and high gastrointestinal portions, laparoscopic approachesand more advanced transgastric, transvaginal or transanal/rectalapproaches.

There is a great need for a method and instruments suitable forendoluminally or laparoscopically excising a tissue sample from areas ina patient's body so as to allow the safe and effective removal of atissue sample, for example a lesion. In particular, there is a need fora method and instruments for excising a determined and precise amount oftissue allowing better control of the visual field during each step ofthe method.

Even if surgical methods for excising tissue samples have been applied,they do not allow endoluminal or laparoscopic approaches. Thedisadvantages of conventional surgical methods are well known; forexample, they are very invasive, the patient needs to be anaesthetisedand the post-operation recovery time is long.

It is an object of the present invention to foresee a method forendoluminally or laparoscopically excising a tissue sample, having adetermined amount and volume, from areas in a patient's body.

Another object of the present invention is to foresee a method forendoluminally or laparoscopically excising a tissue sample suitable forbeing made both for large and small amounts of tissue.

A further object of the present invention is to foresee a method forendoluminally or laparoscopically excising a tissue sample allowingbetter control of the visual field during each step of the method.

Yet another object of the present invention is to foresee a method forendoluminally or laparoscopically excising a tissue sample carried outalong the entire length of the colon up to the caecum.

Yet another object of the present invention is to foresee a safe methodfor endoluminally or laparoscopically excising a tissue sample avoidingperforations.

According to a further aspect, an object of the present invention is toprovide instruments like traction means or a kit suitable for being usedin a laparoscopic or endoluminal method as indicated previously. Afurther object of the present invention is to provide instruments asindicated previously, to allow the safe and effective traction andremoval of a tissue sample.

In brief, the present invention concerns a method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodycomprising the steps of cutting and stapling an appropriate amount oftissue pulled through a window of a surgical stapling device by means oftraction means.

Advantageously, the traction means comprise at least one clip connectedto a suture for putting into traction the tissue through said window.The suture can be pulled directly from outside the patient or can bepulled by grasping means.

Each step of the present method can be carried out by means of or underthe control of a visualization device (endoscope or laparoscope) fordisplaying the field and/or for arranging means suitable for carryingout the steps of the present method.

Advantageously, the step of introducing said at least one clip into thepatient's body and fixing it to the tissue that must be excised iscarried out by means of grasping means that grasp the tissue beforefixing said clip to it.

In accordance with an embodiment of the invention, a sheath isintroduced into the patient's body as a first step. The sheath defines awork channel for receiving the devices that carry out the method,particularly the traction means and the surgical stapling device.Moreover, the sheath is particularly advantageous to avoid perforationsof the walls, in particular of the walls of the colon when the presentmethod is carried out to endoluminally excise a tissue sample of thecolon. Preferably, the sheath is introduced by means of and under thecontrol of a visualization device fixed to the sheath. Advantageously,the surgical stapling device is guided along the work channel of thesheath, sliding on a track of the sheath.

In accordance with another embodiment of the present invention, thesheath defines a first work channel and a second work channel. The firstwork channel is suitable for receiving said traction means and saidsurgical stapling device, the second work channel is suitable forreceiving a visualization device. The suture of the traction means canbe fixed to the inside of the first work channel during the introductionof the sheath or else it can be introduced through the first workchannel by means of positioning grasping means or of a visualizationdevice.

Generally, a proximal portion of the traction means is inserted throughthe window of the surgical stapling device by which the surgicalstapling device is guided by the traction means.

Advantageously, in particular when a large amount of tissue must beexcised, the step of fixing said traction means to at least one portionof tissue that must be excised comprises the step of fixing a pluralityof clips of said traction means to the tissue that must be excised.

Each clip of said plurality of clips is connected to a suture to putinto traction the tissue through said window. The clips can be fixedalong the border of the portion of tissue that must be excised.Otherwise one or more clips can be fixed directly to the portion oftissue that must be excised.

In accordance with an embodiment of the present invention, the tissuethat must be excised is highlighted through a mark or tattoo and theamount of tissue pulled through the window of the surgical staplingdevice is monitored by checking the position of the marks or tattoos.

The aforementioned purposes, the characteristics and advantages of theinvention shall become clear from the following description withreference to the attached drawings, in which:

FIG. 1 is a schematic perspective view of a step of a preferredembodiment of the method for endoluminally or laparoscopically excisinga tissue sample from areas of a patient's body according to the presentinvention;

FIG. 2 is a schematic perspective view of a further step of the methodaccording to the present invention;

FIG. 3 is a schematic perspective view of a further step of the methodaccording to the present invention;

FIGS. 4A to 4C are schematic perspective views of a sequence of phasesof a step of a method according to the present invention;

FIG. 5 is a schematic perspective view of a further step of a methodaccording to the present invention;

FIG. 6 is a schematic side view of a further step of a method accordingto the present invention;

FIG. 7 is a schematic perspective view of a further step of a methodaccording to the present invention;

FIG. 8 is a schematic perspective view of a further step of a methodaccording to the present invention;

FIG. 9 is a schematic perspective view of a further step of a methodaccording to the present invention;

FIG. 10 is a front schematic view of a further step of a methodaccording to the present invention;

FIG. 11 is a schematic perspective view of a further step of a methodaccording to the present invention;

FIG. 12 is a schematic perspective view of a further step of the methodaccording to the present invention;

FIGS. 13 and 13A are schematic perspective views of alternative furthersteps of the method according to the present invention;

FIG. 14 is a schematic perspective view of a step of a furtherembodiment of a method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to the presentinvention;

FIGS. 15-23 are schematic perspective view of further steps of themethod according to the present invention.

FIGS. 1-13 illustrate a first embodiment of a method for endoluminallyor laparoscopically excising a tissue sample from areas in a patient'sbody according to the present invention.

The following description refers both to laparoscopic and endoluminalapproaches in which some steps are carried out by means of and under thecontrol of a visualization device (generic term to indicate avisualization device suitable for the chosen approach). In particular,in the case of the endoluminal approach, the steps are carried outthrough an endoscope.

A portion of tissue comprising the portion of tissue to be excised 12has been generically indicated with 10. This portion can correspond to alesion or other abnormalities that need to be examined.

Generally, the method according to the present invention comprises thesteps of:

providing traction means 14 having a distal portion 14 a, suitable forbeing fixed to at least one portion 12 of the tissue to be excised, anda proximal portion,

introducing said distal portion 14 a of said traction means 14 into thepatient's body and positioning said distal portion 14 a of said tractionmeans 14 close to the tissue to be excised 12, by which at least oneportion of said traction means 14 that extends from said distal portion14 a is positioned in the patient's body,

fixing said distal portion 14 a of said traction means 14 to at leastone portion of tissue to be excised 12,

providing a surgical stapling device 16 having a distal end 16 a with awindow 18 for receiving the tissue to be excised 12 and comprisingcutting and stapling means that act through said window 18,

introducing said surgical stapling device 16 into the patient's body andpositioning said distal end 16 a of the surgical stapling device closeto the tissue to be excised 12,

exerting traction on said traction means 14 by which an amount of tissueis pulled through said window 18,

cutting and stapling said tissue by actuating said cutting and staplingmeans of said surgical stapling device 16 through said window 18.

Finally, all of the devices are withdrawn and the sample fixed to thetraction means is removed from the patient's body.

The example of FIGS. 1-13 shows a method in which said distal portion 14a of said traction means 14 comprises at least one clip 20 by which thestep of fixing said distal portion 14 a of said traction means 14 to atleast one portion of tissue to be excised 12 is carried out by fixingsaid at least one clip of said traction means to the tissue to beexcised. Moreover, the clip 20 is connected to a distal end 22 a of asuture 22 of said traction means to pull the tissue through said window18. Indeed, said suture 22 extends between said distal end 22 a and aproximal end corresponding to the proximal portion of said tractionmeans 14.

Preferably, the clip 20 of said traction means 14 is connected to a ring24 formed at a distal end 24 a of said suture 22 to pull the tissuethrough said window 18.

As shall be described in greater detail, the step of exerting tractionon said traction means 14 can comprise the step of pulling said proximalend of the suture 22 from outside the patient.

According to a different embodiment of the invention, not shown in FIGS.1-13, the step of exerting traction on said traction means can comprisethe step of pulling said proximal end of the suture 22 by means ofgrasping means. An example of this step is shown in FIGS. 22 and 23 withreference to a different embodiment, but it can also be carried out inthe method shown in FIGS. 1-13.

Preferably, the step of exerting traction on said traction means iscarried out under the control of a visualization device 26. Inparticular, during the step of exerting a traction on said tractionmeans 14, a portion of said suture 22 extends through said visualizationdevice 26 (FIG. 13) by which the proximal end of the suture 22 comes outfrom the proximal end of the visualization device 26 and the distal end22 a of the suture 22 comes out from an end of the visualization device26.

According to a different embodiment of the invention, not shown in FIGS.1-13, during the step of exerting traction on said traction means, aportion of said suture 22 extends along an outer surface of avisualization device 26.

As for example shown in FIG. 6, if the traction means comprise at leastone clip 20, it is connected to the suture 22 whilst the clip is formedin the tissue and fixed to it. Preferably, the step of introducing saidat least one clip into the patient's body and fixing it in the tissue tobe excised is carried out by means of grasping means 28 that grasp thetissue before fixing the clip to it, as shown in FIGS. 5 and 6. Forexample, these grasping means can be used to introduce and fix the clipwith the suture to the tissue to be excised and, after having introducedthe surgical stapling device, to pull the proximal end of the suture 22before cutting and stapling said tissue.

In the case in which said grasping means 28 are used, the ring 24 of thesuture 22 is positioned in jaws 30 of said grasping means 28 (FIG. 4).The jaws are closed around said ring 24 before introducing the graspingmeans 28 into the patient's body and before fixing said at least oneclip to the tissue to be excised (FIGS. 5 and 6).

Preferably, as shown in FIGS. 4-6, the step of introducing said tractionmeans 14 into the patient's body is carried out under the control of avisualization device. In particular, the step of introducing saidtraction means 14 into the patient's body comprises the step ofinserting said grasping means 28 through the visualization device 26outside of the patient's body, and then introducing said visualizationdevice and said grasping means into the patient's body to fix saidtraction means to the tissue to be excised. In this case, the suture 22can be inserted into a channel 32 of said visualization device 26,before introducing said visualization device 26 and said grasping means28 into the patient's body. According to a different embodiment that isnot illustrated, the suture 22 can extend along the outside of thevisualization device 26 before introducing said visualization device 26and said grasping means 28 into the patient's body.

The method according to the present invention preferably also comprisesthe step of withdrawing said grasping means 28 and said visualizationdevice 26 after having fixed said means to the tissue to be excised(FIGS. 7 and 8).

According to a generic embodiment of the present invention, the presentmethod also comprises the step of inserting said proximal portion ofsaid traction means 14 into the window 18 of the surgical staplingdevice 16, outside of the patient's body, before introducing thesurgical stapling device 16 into the patient's body. The surgicalstapling device 16 is then guided by said traction means 14 whilst it isintroduced into the patient's body (FIG. 9 with reference to the laststep of the introduction of the surgical stapling device).

If the traction means 14 comprise at least one clip 20 connected to thesuture 22, the last described step is carried out by inserting saidproximal end of said suture 22 into the window 18 of said surgicalstapling device 16, outside of the patient's body, before introducingsaid surgical stapling device 16 into the patient's body. In this case,the surgical stapling device 16 is guided by the suture 22 whilst saidsurgical stapling device 16 is introduced into the patient's body.

Following FIGS. 7-8, the visualization device 26 and the grasping means28 are withdrawn when the traction means have been fixed to the tissueto be excised. Then the suture 22 is inserted into the window 18 outsideof the patient's body. The suture 22 can be re-inserted into thevisualization device 26 that shall preferably be arranged in a concavityof the surgical stapling device. The visualization device 26 follows thesurgical stapling device sliding on the suture (FIGS. 9 and 10).According to a different embodiment that is not illustrated, the suturecan extend outside of the visualization device 26.

According to a generic embodiment of the invention, the present methodcan also comprise a first step of providing a sheath 34 having a distalend 34 a and a proximal end 34 b. Said sheath defines a work channel 36for receiving in particular said traction means 14 and said surgicalstapling device 16. Moreover, the sheath is particularly suitable forprotecting the walls from perforations, in particular the walls of thecolon when the present method is carried out endoluminally in order toexcise a tissue sample of the colon. Moreover, said sheath 34 isintroduced into the patient's body, positioning said distal end 34 a ofthe sheath 34 close to the portion of the tissue to be excised 12,before fixing said traction means 14 to the tissue to be excised. Anexample of this embodiment has been shown in FIGS. 1-13, with referenceto the first embodiment of the present invention. However, it can beused in different embodiments, for example having different types oftraction means or different types of sheaths.

The sheath 34 is preferably made from flexible transparent material. Thedrawings show a schematic view of the sheath 34 after having beeninsufflated; however, it is possible to foresee a sheath of flexiblematerial that naturally expands without insufflation when the devices,particularly the surgical stapling device and the visualization device,are introduced.

According to a generic embodiment of the invention, the sheath 34 isintroduced into the patient's body by means of a visualization devicethat can be the same visualization device referred to as 26 and used indifferent steps of the present invention.

The visualization device 26 is introduced through the sheath 34, fromthe proximal end and to the distal end of the sheath, before introducingsaid sheath into the patient's body. The visualization device 26 has adistal end 26 a and a proximal end.

Thereafter, the visualization device 26 is fixed to the sheath 34. Thesheath 34 with the visualization device 26 is then introduced into thepatient's body (FIG. 1).

Advantageously, the step of fixing the sheath to the visualizationdevice can be carried out as follows. The visualization device 26 isintroduced through the sheath 34 from the proximal end to the distal endof the sheath 34 by which the distal end of the visualization devicecomes out from the distal end of the sheath. Then the visualizationdevice 26 is fixed to the sheath 34 placing an elastic connection sheath38 on the distal end 34 a of the sheath 34 and on the distal end 26 a ofthe visualization device 26, before introducing said sheath 34 into thepatient's body (FIG. 1).

According to an example of the present invention, the visualizationdevice 26 is withdrawn from the sheath 34 before introducing saidtraction means 14 through the sheath 34 (FIGS. 2 and 3). By using anelastic connection sheath 38 to fix the sheath 34 to the visualizationdevice 26, the step of withdrawing said visualization device 26 from thesheath 34 comprises the step of thrusting said visualization device 26,by which the distal end 26 a of the visualization device 26 pulls theelastic connection sheath 38 from the distal end 34 a of the sheath 34(FIG. 2), and then the step of pulling said visualization device 26associated with the sheath outside of said sheath (FIG. 3).

After the positioning of the sheath 34, the step of introducing saidtraction means 14 into the patient's body is carried out by introducingsaid traction means into the work channel 36 of said sheath 34, from theproximal end to the distal end of the sheath, before said traction meansare fixed to the tissue to be excised (FIGS. 4-8). As stated above, thesheath can be insufflated or can be naturally expanded by introducingthe necessary devices.

If the traction means comprise at least one clip 20 connected to thesuture as described above and the step of introducing said at least oneclip 20 into the patient's body and of fixing it to the tissue to beexcised is carried out by grasping means 28, the grasping means arepreferably introduced into the work channel 36 of said sheath 34 tograsp the tissue to be excised before fixing said clip to it. Asdescribed above, the ring 24 of the suture 22 is preferably arranged inthe jaws 30 of said grasping means 28 and then said jaws 30 are closedaround said ring 24 before introducing the grasping means 28 into thepatient's body (FIG. 4), i.e. into the work channel 36 of said sheath34, and before fixing said at least one clip 20 to the tissue to beexcised (FIG. 6). Preferably the step of introducing said traction means14 into the patient's body comprise the step of inserting said graspingmeans 28 through a visualization device outside of the patient's body,and then of introducing said visualization device and said graspingmeans 28 into the work channel 36 of said sheath 34 to fix said tractionmeans to the tissue to be excised (FIG. 5). The visualization device canbe the same visualization device for all of the steps, i.e. thevisualization device referred to as 26 in the drawings. Preferably, thesuture 22 is slotted into a channel 32 of said visualization device 26before introducing said visualization device 26 and said grasping means28 into the work channel 36 of said sheath 34 by which the proximal endof the suture 22 extends outside of the visualization device 26 and ofthe patient's body (FIG. 5). In a different embodiment that is notillustrated, the suture 22 extends along the outside of thevisualization device 26 before introducing said visualization device 26and said grasping means 28 into the work channel 36 of said sheath 34.

Preferably, said grasping means 28 and said visualization device arewithdrawn from the sheath before inserting said surgical staplingdevice.

According to a possible embodiment (not shown), the suture is insertedinto the patient's body before introducing said grasping means. Thegrasping means grasp the distal end of the suture before fixing the atleast one clip to the tissue to be excised. In particular, the suturecan be fixed to the sheath during the introduction of the sheath intothe patient's body.

According to an embodiment of the invention in which the sheath 34 isintroduced into the patient's body, the step of introducing saidsurgical stapling device 16 into the patient's body is genericallycarried out by inserting said surgical stapling device 16 through thesheath 34, into the work channel 36, from the proximal end 34 b to thedistal end 34 a of the sheath 34, before pulling the tissue to beexcised through said window 18 of the surgical stapling device 16 andbefore cutting the tissue pulled through said window 18.

Preferably, the step of introducing said surgical stapling device 16into the patient's body is carried out by guiding said surgical staplingdevice 16 inside the work channel 36 of the sheath 34. The surgicalstapling device 16 is for example guided in the work channel 36 slidingalong a track 40 of the sheath 34, the track extending longitudinallyalong the sheath. Particularly, the surgical stapling device 16comprises an extension 42 suitable for coupling with the track 40 inorder to radially exert a restriction for the surgical stapling device16 with respect to the sheath 34.

Even when the surgical stapling device 16 is guided by the sheath 34 asdescribed above, the proximal portion of said traction means 14 isinserted into the window 18 of the surgical stapling device 16, outsideof the patient's body, before introducing said surgical stapling deviceinto said sheath. Thus, the surgical stapling device 16 is furtherguided by said traction means 14 whilst said surgical stapling device 16is introduced through said sheath 34.

In particular, a preferred embodiment of the present invention can becarried out as follows (FIGS. 1-13).

The first steps of the method according to the present inventioncomprise the steps of:

providing traction means 14 having a distal end 14 a suitable for beingfixed to at least one portion of tissue to be excised and a proximalportion,

providing a surgical stapling device 16 having a distal end 16 a with awindow 18 for receiving the tissue to be excised and comprising cuttingand stapling means operating through said window,

providing a sheath 34 having a distal end 34 a and a proximal end 34 band defining a work channel 36 to receive said traction means 14 andsaid surgical stapling device 16.

Then the method is carried out, as shown in FIG. 1, according to thefollowing steps:

introducing a visualization device 26 through the sheath 34 from theproximal end to the distal end of the sheath, before introducing saidsheath into the patient's body,

fixing the visualization device 26 to the sheath 34 and introducing saidsheath with the visualization device into the patient's body, saiddistal end of said sheath being positioned close to the portion oftissue to be excised (FIG. 1), and

withdrawing the visualization device 26 from the sheath 34 (FIGS. 2-3).

These last steps can be carried out as described above, using an elasticconnection sheath 38 as shown in FIGS. 1-3.

Then the method is carried out as shown in FIGS. 4-7, according to thefollowing steps:

inserting said traction means 14 through the sheath 34, inside the workchannel 36, from the proximal end to the distal end of the sheath, and

fixing said traction means 14 to the at least one portion of tissue tobe excised.

In particular, as described earlier, said distal portion 14 a of saidtraction means 14 comprises at least one clip 20 by which the step offixing said distal portion of said traction means to the at least oneportion of tissue to be excised is carried out by fixing said at leastone clip 20 of said traction means to the tissue to be excised. Saidclip 20 is connected to the distal end of a suture 22 of said tractionmeans 14 to pull the tissue through said window 18, said sutureextending between said distal end 22 a and a proximal end correspondingto the proximal portion of said traction means. The step of introducingsaid at least one clip 20 into the patient's body and of fixing it tothe tissue to be excised is preferably carried out by means of graspingmeans 28 that grasp the tissue before fixing said clip to it. Morepreferably the step of introducing said traction means 14 into thepatient's body comprises the step of inserting said grasping means 28through a visualization device 26 outside of the patient's body, andthen introducing said visualization device 26 and said grasping means 28through the work channel 36, from the proximal end to the distal end ofthe sheath 34. The grasping means 28 and the visualization device 26 arethen withdrawn from the patient's body, leaving the suture in the sheathwith the clip fixed to the tissue to be excised.

Then the method comprises the step of inserting said proximal end ofsaid suture into the window 18 of said surgical stapling device, outsideof the patient's body, before introducing said surgical stapling device16 into said sheath 34. Preferably the proximal end of the suture 22 isre-inserted into the visualization device 26 and the visualizationdevice 26 is arranged in a concavity of the surgical stapling device.

The method also comprises the steps of:

inserting said surgical stapling device 16 through the work channel 36of said sheath 34, sliding on the suture from the proximal end to thedistal end of the sheath, whilst the visualization device follows thesurgical stapling device, and

positioning said distal end of the surgical stapling device close to thetissue to be excised (FIGS. 9-11).

Preferably, said surgical stapling device 16 is also guided inside thework channel 36 sliding along a track 40 of the sheath 34.

Finally, the method comprises the steps of:

exerting a traction on said traction means 14 by which an appropriateamount of tissue is pulled through said window 18 (FIG. 12), and

cutting and stapling said tissue by actuating said cutting and staplingmeans of said surgical stapling device 16 through said window 18 (FIG.13).

Than all of the devices are withdrawn from the patient's body and theexcised sample is taken out by means of the traction means.

The method described earlier is particularly suitable for being carriedout according to an endoluminal approach, using natural or artificialorifices. However, the method described can also be carried outaccording to a laparoscopic approach.

FIGS. 14-23 show a further embodiment of the present invention, asgenerically described earlier. The method described is suitable both foran endoluminal approach and for a laparoscopic approach. As statedabove, the visualization device is a generic device, in particular anendoscope in the case of an endoluminal approach.

In accordance with this embodiment, the method comprises the step ofproviding a sheath 44 having a distal end 44 a and a proximal end 44 b.The sheath 44 defines a first work channel 46 and a second work channel48. The first work channel 46 is suitable for receiving said tractionmeans 14 and said surgical stapling device 16, the second work channel48 is suitable for receiving a visualization device 50.

The sheath is preferably made from flexible transparent material. Thedrawings show a schematic view of the sheath 44 after having beeninsufflated; however, it is possible to foresee a sheath of flexiblematerial that expands naturally without insufflation when the devices,particularly the surgical stapling device and the visualization device,are introduced.

Then the sheath 44 is introduced into the patient's body and the distalend 44 a of the sheath 44 is positioned close to the portion of tissueto be excised before fixing said traction means 14 to the tissue to beexcised 12 (FIG. 14). Advantageously, the sheath 44 is introduced intothe patient's body by means of a visualization device (the visualizationdevice 50 can be used for different steps of the present method).

Also in this case, said distal portion 14 a of said traction means 14comprises at least one clip 20 by which the step of fixing said distalportion 14 a of said traction means 14 to the at least one portion oftissue to be excised is carried out by fixing said at least one clip 20of said traction means 14 to the tissue to be excised (FIG. 18). Asdescribed in the previous embodiment, the clip 20 is connected to thedistal end 22 a of the suture 22 of said traction means 14 to pull thetissue through said window 18. The suture 22 extends between said distalend 22 a and a proximal end 22 b corresponding to a proximal portion 14b of said traction means 14.

As shown in FIG. 15, said suture 22 is introduced into said first workchannel 46 of said sheath 44.

According to an embodiment of the invention, not illustrated, the suture22 is fixed inside said first work channel 46 whilst said sheath 44 isintroduced into the patient's body. The distal end 22 a of said suture22 extends from the distal end 44 a of the sheath 44.

According to a different embodiment, shown in FIGS. 1-2, said suture 22is introduced through said first work channel 46 after having introducedsaid sheath 44 into the patient's body. Also in this case the distal end22 a of said suture 22 extends from the distal end 44 a of the sheath44. According to a possible embodiment, said suture 22 is introducedthrough said first work channel 46 by means of positioning graspingmeans or by means of a visualization device (not shown).

If the traction means comprise at least one clip 20, the step ofintroducing said at least one clip 20 into the patient's body and offixing it to the tissue to be excised is carried out by means ofgrasping means 28 that are preferably introduced through said sheath 44(FIG. 16). Said grasping means 28 grasp said distal end 22 a of thesuture inside the patient's body. Then the grasping means 28 grasp thetissue to be excised 12 before fixing said clip 20 to it. Preferablysaid grasping means 28 are inserted through said visualization device50. The visualization device 50 with the grasping means 28 are insertedinside said second work channel 48 (FIGS. 16 and 17).

After the clip has been fixed to the tissue to be excised, said proximalend 22 b of said suture 22 is inserted into the window 18 of saidsurgical stapling device 16, outside of the patient's body, before saidsurgical stapling device 16 is introduced through said first workchannel 46 of said sheath 44, by which said surgical stapling device 16is guided by said suture 22 (FIG. 20).

The insertion of the surgical stapling device can be carried out underthe visual control of the visualization device 50, or else it ispossible to insert the suture 22 into a different visualization device,after having introduced a proximal end of the suture into the window 18of the surgical stapling device 16, outside of the patient's body. Thevisualization device shall preferably be arranged in a concavity of thesurgical stapling device and shall follow the surgical stapling device16 through the sheath sliding on the suture inside the first workchannel. According to a different embodiment that is not illustrated,the suture can extend outside of the visualization device.

The surgical stapling device reaches the tissue to be excised (FIG. 21)and the tissue is pulled through the window (FIGS. 22 and 23). Duringthe step of pulling said suture, said proximal end 22 b of the suture 22can be pulled directly from outside of the patient or else it can bepulled by grasping means (FIGS. 22 and 23). The grasping means 28 can bethe same ones used to fix the clip. They can be arranged in the secondwork channel or else they can be inserted directly in the first workchannel.

The tissue pulled by the traction means is then cut and stapled byactuating said cutting and stapling means of said surgical staplingdevice 16 through said window 18 (FIG. 23). Finally, all of the devicesare withdrawn from the patient's body and the tissue sample fixed to thesuture is taken out.

As an example, this further embodiment can be carried out as follows.The first steps comprise the steps of:

providing traction means 14 having a distal portion 14 a suitable forbeing fixed to at least one portion of the tissue to be excised and aproximal portion 14 b,

foreseeing a surgical stapling device 16 having a distal end 16 a with awindow 18 for receiving the tissue to be excised and comprising cuttingand stapling means operating through said window 18,

providing a sheath 44 having a distal end 44 a and a proximal end 44 band defining a first work channel 46 and a second work channel 48. Saidfirst work channel 46 is suitable for receiving said traction means 14and said surgical stapling device 16; said second work channel 48 issuitable for receiving said visualization device 50.

Said visualization device 50 is inserted through said second workchannel 48 of said sheath 44 from a proximal end 44 b to a distal end 44a of the sheath, before inserting said sheath into the patient's body.In particular, the visualization device 50 is fixed to the sheath 44 andsaid sheath with the visualization device 50 is then introduced into thepatient's body, said distal end of the sheath being positioned close tothe portion of tissue to be excised. Then the visualization device 50 iswithdrawn from the sheath.

The following steps of the method comprise:

inserting said traction means through said first work channel 46 of saidsheath 44, from the proximal end to the distal end of the sheath, and

fixing said traction means 14 to the at least one portion of the tissueto be excised.

Said distal portion of said traction means comprises at least one clip20 by which the step of fixing said distal portion of said tractionmeans to at least one portion of the tissue to be excised is carried outby fixing said at least one clip of said traction means to the tissue tobe excised. Said clip is connected to a distal end 22 a of a suture 22of said traction means 14 to pull the tissue through said window 18(said suture extends between said distal end 22 a and a proximal end 22b corresponding to the proximal portion 14 b of said traction means 14).Said suture 22 of said traction means 14 can be inserted through saidfirst work channel 46 of said sheath 44 and fixed to it, from theproximal end to the distal end of the sheath, before introducing saidsheath into the patient's body. Alternatively, said suture 22 of saidtraction means 14 is inserted through said first work channel 46 of saidsheath 44, from the proximal end to the distal end of the sheathintroduced into the patient's body (FIG. 15).

The step of introducing said at least one clip 20 into the patient'sbody and of fixing it to the tissue to be excised is carried out bymeans of grasping means 28 that grasp the tissue before fixing said clipto it. Said grasping means 28 can be inserted through a visualizationdevice 50 outside of the patient's body, by which said visualizationdevice 50 and said grasping means 28 are then introduced through saidsecond work channel 48, from the proximal end to the distal end of thesheath.

Jaws 30 of the grasping means 28 grasp the distal end 22 a of the suture22 (in particular a ring formed at the distal end 22 a of the suture 22)inside the patient's body. Then the grasping means 28 grasp the tissueand fix the clip to it.

The following steps of the method comprise:

inserting said proximal end 22 b of said suture 22 into the window 18 ofsaid surgical stapling device 16, outside of the patient's body, beforeintroducing said surgical stapling device 16 into the sheath 44 (FIG.20),

inserting said surgical stapling device 16 through said first workchannel 46 of said sheath 44, from the proximal end to the distal end ofthe sheath, and positioning said distal end of the surgical staplingdevice 16 close to the tissue to be excised (FIGS. 21 and 22); saidsurgical stapling device is preferably guided inside the first workchannel sliding along a track of the sheath,

exerting a traction on said traction means 14 by which an appropriateamount of tissue is pulled through said window 18 (FIG. 22), and

cutting and stapling said tissue by actuating said cutting and staplingmeans of said surgical stapling device 16 through said window 18 (FIG.23).

After having introduced the proximal end 22 b of the suture 22 into thewindow 18, the proximal end 22 b of the suture 22 can be inserted into avisualization device suitable for being arranged in a concavity of thesurgical stapling device 16. The visualization device shall follow thesurgical stapling device during introduction through the sheath.

With reference to all of the embodiments described, the step of fixingsaid traction means 14 to at least one portion of the tissue to beexcised 12 can comprise the step of fixing a plurality of clips 20 ofsaid traction means to the tissue to be excised. Each clip 20 of saidplurality of clips is connected to a suture 22 to pull the tissuethrough said window 18. All of the sutures are inserted into the window18.

According to a possible embodiment, said clips are fixed along a borderof the portion of tissue to be excised. Alternatively, at least one clip20 of said plurality of clips is fixed directly to the portion of tissueto be excised.

With reference to all of the embodiments described, the method accordingto the present invention can comprise the step of highlighting thetissue to be excised through marks or tattoos and, whilst a traction isexerted on said traction means, of monitoring the amount of tissuepulled through the window 18 of the surgical stapling device 16 checkingthe position of said marks or of said tattoos.

Preferably, in all of the embodiments described, the surgical staplingdevice is in an open configuration when it is outside of the patient'sbody (the window 18 is open and preferably has greater dimensions). Thisconfiguration allows easy introduction of the suture through the window18. Then the window is closed so that the stapling device is in a closedconfiguration whilst it is introduced through the sheath (or genericallyinto the patient's body). This configuration is less invasive. Then whenthe surgical stapling device reaches the tissue to be cut, the window 18is reopened in order to cut and staple the tissue.

More advantageously, the surgical stapling device comprises an elongatedstructure, not shown, connected to a handle. The elongated structure ispreferably flexible.

In accordance with a further aspect, the present invention concernstraction means 14 for excising a tissue sample comprising a distalportion 14 a, comprising at least one clip 20 suitable for being fixedto at least one portion 12 of tissue to be excised, and a proximalportion 14 b suitable for being subjected to traction.

Preferably, said at least one clip 20 is suitable for being connected toa distal end 22 a of a suture 22 to pull the tissue to be excised. Thesuture 22 extends between said distal end 22 a and a proximal end 22 bcorresponding to the proximal portion of said traction means 14.

In accordance with a possible embodiment, said at least one clip 20 isconnected to a ring 24 formed at a distal end 24 a of said suture 22 topull the tissue to be excised.

Advantageously, grasping means 28 are foreseen that are suitable forgrasping and pulling said proximal end of the suture 22. Moreover, avisualization device can be foreseen that is suitable for receiving aportion of said suture 22 that extends through a channel of saidvisualization device 26 or else suitable for cooperating with a portionof said suture 22 that extends along an outer surface of a visualizationdevice 26.

In accordance with a possible embodiment, grasping means 28 are foreseenthat are suitable for fixing said clip 20 to the at least one portion oftissue to be excised and for connected said clip to said suture 22.

According to yet another aspect, the present invention concerns a kitfor endoluminally or laparoscopically excising a tissue sample fromareas in a patient's body comprising traction means 14, for example asdescribed above, and a surgical stapling device 16 having a distal end16 a with a window 18 for receiving the tissue to be excised 12 andcomprising cutting and stapling means that act through said window 18.The traction means are suitable for being inserted through said window18 starting from a proximal portion 14 b of the traction meansthemselves.

In accordance with a possible embodiment, the kit also comprises asheath 34 having a distal end 34 a and a proximal end 34 b. Said sheathdefines a work channel 36 for receiving the traction means 14 and thesurgical stapling device 16.

In accordance with a different embodiment the kit comprises a sheath 44having a distal end 44 a and a proximal end 44 b, in which said sheath44 defines a first work channel 46 and a second work channel 48. Thefirst work channel 46 is suitable for receiving the traction means 14and the surgical stapling device 16; the second work channel 48 issuitable for receiving a visualization device 50.

Preferably, the sheath is made from flexible transparent materialsuitable for being insufflated or else suitable for being naturallywidened through the insertion of the devices (traction means, staplingdevice, visualization devices, . . . )

In accordance with a possible embodiment, said sheath comprises a track40 that extends longitudinally along the sheath itself and the surgicalstapling device 16 is suitable for sliding inside the sheath along saidtrack. Preferably, the surgical stapling device 16 comprises anextension 42 suitable for coupling with the track 40 in order toradially exert a restriction for the surgical stapling device 16 withrespect to the sheath 34.

In accordance with a possible embodiment, the kit according to thepresent invention also comprises an elastic connection sheath 38suitable for slotting onto the distal end 34 a of the sheath 34 and ontoa distal end 26 a of a visualization device 26 to connect them in theinsertion step.

From the above description, it is clear that an improved method forendoluminally or laparoscopically excising a tissue sample is foreseen,having a specific amount and volume, from areas in a patient's body.Traction means and a kit are also foreseen that allow precise and safetraction of the tissue. Even if the aforementioned invention has beendescribed in detail for the sake of clarity, it is obvious thatmodifications can be made without departing from the attached claims.

1. A method for endoluminally or laparoscopically excising a tissuesample from areas in a patient's body, the method comprising the stepsof: providing traction means (14) having a distal portion (14 a)suitable for being fixed to at least one portion (12) of the tissue tobe excised and a proximal portion, introducing said distal portion (14a) of said traction means (14) into the patient's body and positioningsaid distal portion (14 a) of said traction means (14) close to thetissue to be excised (12), by which at least one portion of saidtraction means (14) that extends from said distal portion (14 a) ispositioned in the patient's body, fixing said distal portion (14 a) ofsaid traction means (14) to at least one portion of tissue to be excised(12), providing a surgical stapling device (16) having a distal end (16a) with a window (18) for receiving the tissue to be excised (12) andcomprising cutting and stapling means that act through said window (18),introducing said surgical stapling device (16) into the patient's bodyand positioning said distal end (16 a) of the surgical stapling deviceclose to the tissue to be excised (12), exerting a traction on saidtraction means (14) by which an amount of tissue is pulled through saidwindow (18), cutting and stapling said tissue by actuating said cuttingand stapling means of said surgical stapling device (16) through saidwindow (18), wherein the step of providing the traction means comprises:forming a ring (24) at a distal end (22 a) of a suture (22), said ring(24) defining an eyelet, and connecting a clip (20) to said ring (24),wherein said suture (22), ring (24) and clip (20) form said fractionmeans, wherein the step of introducing said distal portion (14 a) ofsaid traction means (14) into the patient's body comprises: positioningthe ring (24) of the suture (22) between jaws of a grasping means (28)with one jaw of said jaws hooking into said eyelet, introducing thegrasping means (28) hooked into the eyelet of the ring (24) into thepatient's body, wherein the step of fixing said distal portion (14 a) ofsaid traction means (14) to the portion of tissue to be excisedcomprises grasping the tissue by means of said grasping means (28) andthen fixing said clip to the tissue by means of said grasping means(28).
 2. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 1, inwhich said suture is extended between said distal end (22 a) and aproximal end (22 b) corresponding to the proximal portion (14 b) of saidtraction means (14).
 3. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 2, in which the step of exerting a traction on said traction means(14) comprises the step of pulling said proximal end (22 b) of thesuture (22) from outside of the patient's body.
 4. A method forendoluminally or laparoscopically excising a tissue sample from areas ina patient's body according to claim 3, in which the step of exerting atraction on said traction means (14) is carried out under the visualcontrol of a visualization device.
 5. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 4, in which, during the step of exerting a tractionon said traction means (14), a portion of said suture (22) extendsthrough said visualization device, said proximal end of the suturecoming out from a proximal end of the visualization device and saiddistal end of the suture coming out from a distal end of thevisualization device.
 6. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 2, in which the step of exerting a traction on said traction means(14) comprises the step of pulling said suture by means of said graspingmeans (28).
 7. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 6, inwhich the step of exerting a traction on said traction means (14) iscarried out under the visual control of a visualization device.
 8. Amethod for endoluminally or laparoscopically excising a tissue samplefrom areas in a patient's body according to claim 2, in which a step ofintroducing said clip (20) into the patient's body and said step offixing said clip to the tissue to be excised is carried out by means ofsaid grasping means that grasp the tissue before fixing the clip to saidtissue.
 9. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 8, inwhich said clip and said suture are introduced into the patient's bodyby means of said grasping means (28).
 10. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 9, in which jaws (30) of said grasping means (28)grasp the distal end (22 a) of the suture (22) before introducing thegrasping means into the patient's body and before fixing said at leastone clip to the tissue to be excised.
 11. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 10, in which, during the step of grasping the distalend (22 a) of the suture (22), a ring (24) formed at the distal end ofthe suture (22) is positioned in said jaws of the grasping means, andthe jaws are closed around said ring before introducing said graspingmeans into the patient's body and before fixing said at least one clipto the tissue to be excised.
 12. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 8, in which the step of introducing said at least oneclip (20) into the patient's body and of fixing said clip to the tissueto be excised is carried out under the control of a visualizationdevice.
 13. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 12, inwhich the step of introducing said traction means into the patient'sbody comprises the step of inserting said grasping means through saidvisualization device outside of the patient's body, and then ofintroducing said visualization device and said grasping means into thepatient's body to fix said traction means to the tissue to be excised.14. A method for endoluminally or laparoscopically excising a tissuesample from areas in a patient's body according to claim 13, in whichsaid suture is inserted in a channel (32) of the visualization devicebefore introducing said visualization device and said grasping meansinto the patient's body, the proximal end (22 b) of the suture (22)extending outside of the visualization device and of the patient's body.15. A method for endoluminally or laparoscopically excising a tissuesample from areas in a patient's body according to claim 13, alsocomprising the step of withdrawing said grasping means and saidvisualization device after having fixed said traction means to thetissue to be excised.
 16. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 2, also comprising the step of inserting said proximal end of saidsuture into the window (18) of the surgical stapling device, outside ofthe patient's body, before introducing said surgical stapling deviceinto the patient's body.
 17. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 16, in which said surgical stapling device is guidedby said suture whilst said surgical stapling device is introduced intothe patient's body.
 18. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 16, in which said proximal end of said suture is inserted throughor extended outside a visualization device, the visualization devicefollowing said surgical stapling device during introduction into thepatient's body.
 19. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 18, in which said visualization device is arranged in a concavityof said surgical stapling device.
 20. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 2, in which the step of fixing said traction means toat least one portion of tissue to be excised comprises the step offixing a plurality of clips (20) of said traction means to the tissue tobe excised, each clip of said plurality of clips being connected to asuture to pull the tissue through said window.
 21. A method forendoluminally or laparoscopically excising a tissue sample from areas ina patient's body according to claim 20, in which said plurality of clips(20) are fixed along a border of the portion of the tissue to beexcised.
 22. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 20, inwhich at least one clip of said plurality of clips (20) is fixeddirectly to the portion of the tissue to be excised.
 23. A method forendoluminally or laparoscopically excising a tissue sample from areas ina patient's body according to claim 1, also comprising the step ofinserting said proximal portion of said traction means into the window(18) of the surgical stapling device (16), outside of the patient'sbody, before introducing said surgical stapling device into thepatient's body.
 24. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 23, in which said surgical stapling device is guided by saidtraction means (14) whilst said surgical stapling device is introducedinto the patient's body.
 25. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 1, also comprising the steps of: providing a sheath(34) having a distal end (34 a) and a proximal end (34 b), said sheathdefining a work channel (36) to receive said traction means (14) andsaid surgical stapling device (16) and to protect the walls fromperforation, introducing said sheath into the patient's body andpositioning said distal end close to the portion of tissue to be excisedbefore fixing said traction means to the tissue to be excised.
 26. Amethod for endoluminally or laparoscopically excising a tissue samplefrom areas in a patient's body according to claim 25, also comprisingthe steps of: introducing a visualization device through the sheath,from the proximal end to the distal end of the sheath, beforeintroducing said sheath into the patient's body, said visualizationdevice having a proximal end and a distal end, fixing the visualizationdevice to the sheath and introducing said sheath with the visualizationdevice into the patient's body.
 27. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 26, in which said visualization device is introducedthrough the sheath from the proximal end to the distal end of the sheathby which the distal end of the visualization device comes out from thedistal end of the sheath, and in which said visualization device isfixed to the sheath placing an elastic connection sheath on the distalend of the sheath and on the distal end of the visualization device,before introducing said sheath into the patient's body.
 28. A method forendoluminally or laparoscopically excising a tissue sample from areas ina patient's body according to claim 26, in which said visualizationdevice is withdrawn from the sheath before introducing said tractionmeans (14) through said sheath.
 29. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 28, in which the step of withdrawing saidvisualization device from said sheath comprises the step of thrustingsaid visualization device by which the distal end of the visualizationdevice pulls the elastic connection sheath from the distal end of thesheath and then the step of pulling said visualization device outside ofsaid sheath.
 30. A method for endoluminally or laparoscopically excisinga tissue sample from areas in a patient's body according to claim 25, inwhich the step of introducing said traction means into the patient'sbody is carried out by introducing said traction means into the workchannel (36) of the sheath (34), from the proximal end to the distal endof the sheath, before fixing said traction means to the tissue to beexcised.
 31. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 30, inwhich said clip attached to said suture is introduced into the patient'sbody and fixed to the tissue to be excised by means of said graspingmeans that are inserted into the work channel of said sheath.
 32. Amethod for endoluminally or laparoscopically excising a tissue samplefrom areas in a patient's body according to claim 31, in which said clipand said suture are introduced into the work channel of said sheath bymeans of said grasping means.
 33. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 32, in which jaws of said grasping means grasp thedistal end of the suture before the grasping means are introduced intothe work channel of the sheath and before fixing said at least one clipto the tissue to be excised.
 34. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 33, in which, during the step of grasping the distalend of the suture, a ring (24) formed at the distal end of the suture ispositioned in jaws of said grasping means and said jaws are closedaround said ring before introducing the grasping means into the workchannel of said sheath and before fixing said at least one clip to thetissue to be excised.
 35. A method for endoluminally or laparoscopicallyexcising a tissue sample from areas in a patient's body according toclaim 31, in which the step of introducing said at least one clip intothe patient's body and of fixing said clip to the tissue to be excisedis carried out under the visual control of a visualization device.
 36. Amethod for endoluminally or laparoscopically excising a tissue samplefrom areas in a patient's body according to claim 35, in which the stepof introducing said traction means into the patient's body comprises thestep of inserting said grasping means through said visualization deviceoutside of the patient's body, and then of introducing saidvisualization device and said grasping means into the work channel ofsaid sheath to fix said traction means to the tissue to be excised. 37.A method for endoluminally or laparoscopically excising a tissue samplefrom areas in a patient's body according to claim 36, in which saidsuture is slotted into a channel of said visualization device beforeintroducing said visualization device and said grasping means into thework channel of the sheath, the proximal end of the suture extendingoutside of said visualization device and of the patient's body.
 38. Amethod for endoluminally or laparoscopically excising a tissue samplefrom areas in a patient's body according to claim 36, also comprisingthe step of withdrawing said grasping means and said visualizationdevice from the work channel of the sheath after having fixed saidtraction means to the tissue to be excised.
 39. A method forendoluminally or laparoscopically excising a tissue sample from areas ina patient's body according to claim 31, in which the step of introducingsaid surgical stapling device into the patient's body is carried out byinserting said surgical stapling device through the sheath, inside thework channel, from the proximal end to the distal end of the sheath, theproximal end of the suture being inserted into the window of thesurgical stapling device.
 40. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 39, in which the suture is re-inserted into thevisualization device from outside of the patient's body and thevisualization device follows the surgical stapling device and isarranged in a concavity of the surgical stapling device duringintroduction into the sheath.
 41. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 25, in which the step of introducing said surgicalstapling device into the patient's body is carried out by inserting saidsurgical stapling device through said sheath, inside of the workchannel, from the proximal end to the distal end of the sheath, beforepulling the tissue to be excised through said window of the surgicalstapling device and before cutting the tissue pulled through saidwindow.
 42. A method for endoluminally or laparoscopically excising atissue sample from areas in a patient's body according to claim 41, inwhich the step of introducing said surgical stapling device into thepatient's body is carried out by guiding said surgical stapling deviceinside the work channel of the sheath.
 43. A method for endoluminally orlaparoscopically excising a tissue sample from areas in a patient's bodyaccording to claim 42, in which said surgical stapling device is guidedinside the work channel sliding along a rail of the sheath.
 44. A methodfor endoluminally or laparoscopically excising a tissue sample fromareas in a patient's body according to claim 41, in which said proximalportion of said traction means is inserted into the window of saidsurgical stapling device, outside of the patient's body, beforeintroducing said surgical stapling device into said sheath.
 45. A methodfor endoluminally or laparoscopically excising a tissue sample fromareas in a patient's body according to claim 44, in which said surgicalstapling device is guided by said traction means whilst the surgicalstapling device is introduced into said sheath.